Characterizing the Impact of Presbyphonia on Social Interaction

Not Applicable

Not yet recruiting

• Conditions: Presbyphonia
• Interventions: Other: PhoRTE Program; Other: University of California Los Angeles (UCLA) Loneliness Scale; Other: Social Disconnectedness Scale; Other: Patient Health Questionnaire 9; Other: Aging Voice Index; Other: The Edmonton Frail Scale; Other: Vocal Effort Scale; Other: Montreal Cognitive Assessment; Other: Voice Handicap Index-10; Other: Voice Problem Impact Scales; Other: Cough Severity Index; Procedure: Laryngoscopy; Other: Acoustic, perceptual, and aerodynamic assessments

• Registration Number: NCT06441136
• Lead Sponsor: Matthew R. Hoffman

Brief Summary

The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression. A series of questionnaires, voice assessments, and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life.

Detailed Description

During the study visit, all subjects (including the control group) will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice. All participants will undergo audiometry to assess hearing (with hearing aids if used at home). If they do not pass the hearing test, they will be screened out of the study.

Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each, repeating six standard sentences, and 20 seconds of natural conversational speech. Using this voice recording, the following assessments and measurements will be obtained: CAPE-V rating (Consensus auditory perceptual evaluation of voice), Cepstral peak prominence (measurement of dysphonia), fundamental frequency, signal-to-noise ratio, and voice type components (captures breathiness).

Subjects will then be asked to produce a train of /pi pi pi/ at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow. Five trials will be performed. The following measurements will be obtained: mean flow rate, subglottal pressure, and vocal efficiency.

Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds. During this procedure, the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds. This part of the study takes about 2 minutes to complete. The parameters to be measured for this are: bowing index of the vocal folds and normalized glottal gap.

For the second part of this study, subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy. Prior to therapy, for two weeks, participants will take pictures when their voice disorder may be affecting them or ability to socialize. Brief journal entry will be completed. Photos will be collected, printed, and used as memory recall tool for a pre-treatment semi-structured interview. Interviews will be conducted, approximately 45-60 minutes induration. Both online and in-person options will be available to facilitate participation. An interview guide will include questions designed to assess participants' perception of voice and how voice affects social participation.

Subjects will then complete PhoRTE therapy. Participants perform 5 vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.

Following therapy, participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy. Interviews will address experience with voice therapy, and any changes after voice therapy.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-05
• Study Start: 2024-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Diagnosis of presbyphonia with findings of presbylaryngis on videostroboscopy, with findings of bilateral true vocal fold atrophy and normal vocal fold motion bilaterally
• Able to complete all questionnaires and voice assessment tasks
• Normal to mild hearing loss in aided condition (with hearing aids)

Read More

Exclusion Criteria

• Liquid dysphagia or pneumonia in the last year
• Vocal fold lesion/scar/motion impairment
• Neurologic disorder affecting the voice
• Montreal cognitive assessment score <26 or <25 if 12 or fewer years of formal education

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	PhoRTE Program	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Social Disconnectedness Scale	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	University of California Los Angeles (UCLA) Loneliness Scale	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Laryngoscopy	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Acoustic, perceptual, and aerodynamic assessments	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Patient Health Questionnaire 9	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Aging Voice Index	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	The Edmonton Frail Scale	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Vocal Effort Scale	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Montreal Cognitive Assessment	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Voice Problem Impact Scales	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Voice Handicap Index-10	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program	Cough Severity Index	PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
The Effect on Loneliness with the PhoRTE Voice Therapy Program	Baseline and at 3 months	Loneliness will be measured using the University of California - Los Angeles (UCLA) Loneliness Scale questionnaire at baseline and at the end of the 4-week PhoRTE program. The UCLA Loneliness Scale is a 20-item scale with each item rated on a 4-point Likert scale (ranging from 1, "never," to 4, "often") and the total score can range from 20 to 80, with higher scores indicating greater feelings of loneliness.

Secondary Outcome Measures

Name	Time	Method
The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program	Baseline and at 3 months	Social disconnectedness will be measured using the Social Disconnectedness Scale questionnaire at baseline and at the end of the 4 week PhoRTE program. The Social Disconnectedness Scale is based on a 15-item scale with each item rated on their own scale depending on the question asked (ex: ranging from 0, "never" to 7, "several times a week" or indicating number of individuals in a social network). The total score can range from 2 to 72, with lower scores indicating greater levels of social disconnectedness.
The Effect on Depression with the PhoRTE Voice Therapy Program	Baseline and at 3 months	Levels of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at the end of the 4 week PhoRTE program. The PHQ-9 is a 9-item scale with each item rated on a scale (ranging from 0, "not at all," to 3, "nearly every day") and the total score can range from 0-27 with higher scores indicating greater feelings of depression.